NEOSS PROACTIVE IMPLANT

Implant, Endosseous, Root-form

NEOSS, LTD.

The following data is part of a premarket notification filed by Neoss, Ltd. with the FDA for Neoss Proactive Implant.

Pre-market Notification Details

• Device ID: K083561
• 510k Number: K083561
• Device Name: NEOSS PROACTIVE IMPLANT
• Classification: Implant, Endosseous, Root-form
• Applicant: NEOSS, LTD. 901 KING STREET SUITE 200 Alexandria, VA 22314
• Contact: Cherita James
• Correspondent: Cherita James; NEOSS, LTD. 901 KING STREET SUITE 200 Alexandria, VA 22314
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-12-02
• Decision Date: 2009-02-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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